跳至主要内容
临床试验/NCT05704439
NCT05704439撤回不适用

Cardiovascular Risk in Epilepsy: Pilot Feasibility and Efficacy Study of Neurologist-Initiated Treatment of Hypertension and Hyperlipidemia in an Underserved Minority Population in Los Angeles

University of California, Los Angeles0 个研究点开始时间: 2024年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Change in ACC-ASCVD score from baseline

研究概览

简要总结

Epilepsy is a disabling and lethal neurological disease which affect 3.47 million Americans. Significant health care disparities exist in people with epilepsy (PWE). Hypertension and hyperlipidemia are highly prevalent and often go undertreated, and cardiovascular (CV) mortality is higher in people with epilepsy (PWE) than the general population. Preliminary data from our group shows that PWE have higher ACC-ASCVD risk scores than an age matched NHANES cohort without epilepsy. Preliminary data also demonstrate mortality rates in PWE due to hypertension, stroke, and diabetes are rising in the US, counter to the US general population.

This proposal seeks to test the feasibility, acceptability, and preliminary efficacy of a new care model for the underserved PWE in a public health setting. In this new model, neurologists guided by standardized treatment algorithms (ACC-ASCVD estimator+) propose and initiate pharmacological interventions for hypertension and hyperlipidemia.

详细描述

Epilepsy is a disabling and lethal neurological disease which affect 3.47 million Americans. Significant health care disparities exist in people with epilepsy (PWE). PWE are more likely to be Hispanic, Black, developmentally disabled and unemployed. Hypertension and hyperlipidemia are highly prevalent and often go undertreated, and cardiovascular (CV) mortality is higher in people with epilepsy (PWE) than the general population. Preliminary data from our group shows that PWE have higher ACC-ASCVD risk scores than an age matched NHANES cohort without epilepsy. Preliminary data also demonstrate mortality rates in PWE due to hypertension, stroke, and diabetes are rising in the US, counter to the US general population.

PWE on Medicaid, Medi-Cal and without insurance are more likely to experience delays to treatment and follow aberrant care pathways. Unexpected seizures and status epilepticus often result in transport to community and public health hospitals, where they are referred to neurology clinics, a process which may bypass primary care. As a result, PWE may have as their primary point of contact neurologists who traditionally do no monitor or treat hypertension or hyperlipidemia. This leads to gaps in care and missed opportunities to reduce CV risk.

This proposal seeks to test the feasibility, acceptability, and preliminary efficacy of a new care model for the underserved PWE in a public health setting. In this new model, neurologists guided by standardized treatment algorithms (ACC-ASCVD estimator+) propose and initiate pharmacological interventions for hypertension and hyperlipidemia.

We propose enrolling 150 subjects ages 40-79 with untreated or incompletely treated hypertension and/or hyperlipidemia. Subjects will be randomized 2:1 to Neurologist-initiated treatment (Model 1) versus usual care (Model 2). Subjects will be evaluated for blood pressure, blood chemistries, lipids, and HgA1C at baseline, one and three months. At 3-months, subjects randomized to usual care (Model 2) will be offered treatment if not yet initiated by primary care. If successful, results of this pilot study will provide needed feasibility and preliminary efficacy data for a large multicenter randomized trial of Neurologist initiated treatment of cardiovascular risk in the underserved with epilepsy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Stroke or cerebral hemorrhage < 1 year
  • Documented poor compliance with treatment
  • If intellectually disabled, if there is no caregiver to support or initiate therapy
  • Pregnancy or person actively trying to become pregnant
  • Blood Pressure > 180/110
  • Known secondary cause of hypertension that causes concern regarding safety of the protocol.
  • Arm circumference too large or small to allow accurate blood pressure measurement with available devices
  • Diabetes mellitus,
  • Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
  • eGFR < 20 ml/min /1.73m2 or end-stage renal disease (ESRD)
  • Cardiovascular event, procedure or hospitalization for unstable angina within last 3 months
  • Symptomatic heart failure within the past 6 months
  • A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years
  • Any factors judged by the clinic team to be likely to limit adherence to interventions.
  • Failure to obtain informed consent from participant
  • Any organ transplant

研究组 & 干预措施

Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia

Active Comparator

Neurologist Initiation of antihypertensive or treatment for hyperlipidemia

干预措施: Neurologist Initiated Treatment (Drug)

Model 2-Usual Care

Placebo Comparator

Usual care

干预措施: Placebo (Other)

结局指标

主要结局

Change in ACC-ASCVD score from baseline

时间窗: 3-months

Percent change in ACC-ASCVD score (ACC-ASCVD) compared with baseline

次要结局

  • Systolic blood pressure(3 months)
  • Total Cholesterol(3 months)
  • LDL-low density lipoprotein(3 months)
  • Acceptability Rate(3 months)
  • Compliance(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Degiorgio, MD FAAN

Professor of Neurology in Residence

University of California, Los Angeles

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